Interface accessory for use with an aerosol inhalation system

ABSTRACT

An aerosol inhalation system includes a single source of gas and a Y-connector having a first port in fluid communication with the gas source via a conduit. The system also has an accessory having a main conduit body that fluidly connected to the Y-connector via a conduit to permit gas from the single source to flow through the main conduit body. The accessory includes a patient interface conduit that delivers aerosolized medication to a mouth of the patient. A nebulizer is sealingly and removably disposed within the main conduit body and includes a gas inlet port that is fluidly connected to the Y-connector to permit gas from the single source to flow into the nebulizer to create the aerosolized medication that is delivered into the main conduit body and to the patient through the patient interface conduit.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is a continuation-in-part of U.S. patentapplication Ser. No. 11/414,737 filed Apr. 27, 2006, which is acontinuation-in-part of U.S. patent application Ser. No. 11/121,688,filed May 3, 2005, (now U.S. Pat. No. 7,445,006, issued on Nov. 4,2008), each of which is hereby incorporated by reference in itsentirety.

TECHNICAL FIELD

The present invention relates to inhalation equipment and moreparticularly, relates to aerosol inhalation systems including aninterface (accessory) for use in the system between a conventional partof the inhalation equipment, such as a generator and the patient toprovide in a number of applications a completely closed system thatensures that the medication delivered to the patient has a fixedconcentration over time.

BACKGROUND

Aerosol inhalation equipment is commonly used as a means to delivermedication in all aerosolized form to a patient. Aerosolized medicationis typically used to treat patients with respiratory conditions, such asasthma or chronic obstructive pulmonary disease (COPD). For example,inhalation equipment is a common means for delivering, medication tocounter certain aliments of a patient population, including reactiveairway disease, asthma, cystic fibrosis, etc.

It is generally accepted that effective administration of medication asaerosol depends on the delivery system and its position in relation tothe patient. Aerosol particle deposition is influenced by particle size,ventilatory pattern, and airway architecture and effective medicationresponse is also influenced by the dose of the medication used.

An aerosol delivery system includes three principal elements, namely agenerator, a power source, and an interface. Generators include smallvolume nebulizers (SVN), large volume nebulizers (LVN), metered doseinhalers (MDI), and dry powder inhalers (DPI). The power source is themechanism by which the generator operates or is actuated and includescompressed gas for SVN and LVN and self-contained propellants for MDI.The interface is the conduit between the generator and the patient andincludes spacer devices/accessory devices with mouthpieces or facemasks. Depending on the patient's age (ability) and coordination,various interfaces are used in conjunction with SVN and MDI in order tooptimize drug delivery.

A SVN is a jet nebulizer that is powered by a compressed gas source. Themedication is displaced tip a capillary tube from the nebulizer'sreservoir and is dispersed continuously as aerosolized particles. Theaerosolized particles are spontaneously inhaled by the patient ordelivered in conjunction with positive-pressure breaths. Typically, forpatients greater than 3 years who are spontaneously breathing without anartificial airway and are able to cooperate, a mouthpiece with anextension reservoir should be used. For patients unable to negotiate amouthpiece, typically children under 3 years, a face mask should beused.

An MDI is essentially a pressurized canister that contains a medicationand propellant. Actuation of the MDI results in the ejection of one doseof medication as aerosolized particles, which can be spontaneouslyinhaled by the patient or delivered in conjunction withpositive-pressure breaths. A spacer device/accessory device should beused with an MDI. A spacer device enhances delivery by decreasing thevelocity of the particles and reducing the number of large particles. Aspacer device with a one-way valve, i.e., holding chamber, eliminatesthe need for the patient to coordinate actuation and inhalation andoptimizes drug delivery. A spacer device without valves requirescoordination between inhalation and actuation. The MDI with spacerdevice and face mask is appropriate for patients, typically less than 3years, unable to use a mouthpiece.

A DPI is a breath-actuated device that uses a gelatin capsulecontaining, a single dose of medication and a carrier substance to aidin the dispersion of the drug. The capsule is inserted into the deviceand punctured. The patient's inspiratory flow disperses the dryparticles and draws them into the lower airways. In spontaneouslybreathing patients, this device is appropriate in patients who are ableto achieve a certain inspiratory flow, such as equal to or greater than50 L/min. This will typically correspond to children about 6 years orgreater.

A LVN can be used to deliver a dose of medication continuously over aperiod of time. A LVN is powered by a compressed gas source, and a facemask is typically used as the interface.

The two primary means for delivering aerosolized medication to treat amedical condition is an MDI or a nebulizer. MDI medication (drug)canisters are typically sold by manufacturers with a boot that includesa nozzle, an actuator, and a mouthpiece. Patients can self-administerthe MDI medication using the boot alone but the majority of patientshave difficulty in synchronizing the actuation of the MDI canister andpatient inhalation and improve the delivery and improve the delivery ofmedication by decreasing oropharynigeal deposition of the aerosol drug.

Many valved chambers of this type are commercially available. Examplesof such spacers include but are not limited to those structuresdisclosed in U.S. Pat. Nos. 4,470,412; 5,012,803; 5,385,140; 4,637,528;4,641,644; 4,953,545; and U.S. patent application publication No.2002/0129814. These devices are expensive and may be suitable forchronic conditions that require frequent use of MDI inhalers providedthe cost and labor involved in frequent delivery of medication isacceptable to the patient. However, under acute symptoms, such devicesmay fail to serve the purpose and lead to an inadequate delivery ofmedication.

Aerosol delivery systems that use standard small volume nebulizers arecommonly used in acute conditions as they are cheap and overcome theinhalation difficulties associated with actuation of MDI andsynchronization of inhalation by the patient. Nebulizers are fraughtwith numerous problems as well. The medication dose used is about 10times of that used with an MDI and hence the increased cost without anyadded proven clinical benefit. Secondly, the majority of the nebulizedmedication is wasted during exhalation. Thirdly, the time taken todeliver the medication is several times that of an MDI and the laborcost of respiratory therapist may outweigh the benefits of nebulizerscompared with MDIs. Breath actuated nebulizers(s) with reservoir havebeen designed to overcome the medication waste. An example of this typeof device is found in U.S. Pat. No. 5,752,502. However, these devicesare expensive and still have all the other problems associated withnebulizer use alone. Other examples of aerosol inhalation devices can befound in U.S. Pat. No. 4,210,155, in which there is a fixed volume mistaccumulation chamber for use in combination with a nebulizer and a TEEconnection.

Problems with prior art devices include that the devices significantlywaste medication, they provide a non-uniform concentration of deliveredmedication, they are expensive, and they are difficult to use. Many ofthese devices are commercially available in which the nebulizer isdirectly attached to the TEE connector without any mixing chamber. Allof the aforementioned devices can be used with either an MDI or anebulizer but not both, and hence, face the difficulty associated witheither system alone. Other devices have tried to overcome the aboveproblems by incorporating a mixing chamber in the device withadaptability to be used with an MDI or standard nebulizer. U.S. patentapplication publication No. 2002/0121275 disclosed a device having theabove characteristics, however, this device is plagued with problemsthat are typical to those types of devices. As with other conventionaldevices, the disclosed device, like the other ones, fails to incorporatesome of the key features necessary for enhanced aerosol delivery.

In general, each of the prior art devices suffers from the followingdeficiencies: (1) the entrained airflow in the device interferes withthe MDI plume as well as the plume generated by a nebulizer resulting inincreased impaction losses of aerosol generated by either an MDI ornebulizer; (2) the device does not have the ability to deliver a desiredprecise fraction of inspired oxygen to a hypoxic patient andsimultaneously deliver aerosol medication with either a metered doseinhaler (MDI) or a nebulizer; (3) the device can not deliver a (as witha desired density to improve aerosol delivery and a desired fraction ofinspired oxygen to a hypoxemic patient; (4) the device does not have theability to deliver different density gases with a desired fraction ofinspired oxygen simultaneously while retaining the ability to deliveraerosol medication at the same time with either an MDI or a nebulizer;(5) the device does not have the ability to deliver a mixture ofmultiple gases to a patient and simultaneously maintain a desiredfraction of inspired oxygen; (6) the device does not serve as a facemaskfor delivering varying concentrations of inspired oxygen from room airto 100% but serves solely as an aerosol delivery device; (7) the devicedoes not have a reservoir chamber—either as a bag or as a large volumetubing to store nebulized medication that is otherwise wasted duringexhalation (The holding chamber of this type of device varies from 90 ccto 140 cc and is not enough to serve as a reservoir for the volume ofnebulized medication generated during exhalation is wasted); (8) thereis no mechanism in the device to prevent entrainment of room air whichforms the bulk of volume during inhalation (the fraction of inspiredoxygen and the density of the gas mixture inhaled by the patient mayvary with every breath with the device depending on the volume ofentrained room air which may vary with each breath); (9) the device doesnot have any valve system to prevent exhaled carbon dioxide fromentering the holding chamber—rebreathing of carbon dioxide from theholding chamber on subsequent inhalation can be extremely detrimental toa patient and extremely dangerous under certain clinical conditions;(10) the device does not have the capability of delivering medicationwith an MDI and a nebulizer simultaneously; and (11) the device has afixed volume-holding chamber which makes the device extremely large andcumbersome to deliver medication.

What is needed in the art and has heretofore not been available is asystem that overcomes the above deficiencies and incorporatesfunctionality to make the device a compacts user friendly, economical,and multipurpose aerosol device for both acute and chronic use witheither an MDI or a nebulizer or with both devices simultaneously aswarranted by the patient's clinical circumstances.

SUMMARY

According to one embodiment, an aerosol inhalation system includes asingle source of gas and a Y-connector having a first port in fluidcommunication with the gas source via a first conduit and second andthird ports. The system also has an accessory having a main conduit bodythat includes a first leg, a second leg, and a third leg, all of whichare in fluid communication with the main conduit section. The first leg,is fluidly connected to the second port of the Y-connector via a secondconduit to permit gas from the single source to flows though the firstleg, the accessory including a patient interface conduit that deliversaerosolized medication to a mouth of the patient.

A nebulizer is sealingly and removably disposed within the third leg andincludes a gas inlet port that is fluidly connected to the third port ofthe Y-connector to permit gas from the single source to flow into thenebulizer to create the aerosolized medication that is delivered intothe main conduit body and to the patient through the patient interfaceconduit.

According to another embodiment, an aerosol inhalation system includes asingle source of gas and a Y-connector having a first port in fluidcommunication with the gas source via a first conduit and second andthird ports. The system further includes an accessory having a mainconduit body that includes a first leg, a second leg, and a third leg,all of which are in fluid communication with the main conduit section.The first leg is fluidly connected to the second port of the Y-connectorvia a second conduit that is connected to the second port and a gas portassociated with the first leg to permit gas from the single source toenter and flow through the first leg. The accessory also includes apatient interface conduit that delivers aerosolized medication to amouth of the patient.

A nebulizer is sealingly and removably disposed within the third leg andincludes a gas inlet port that is fluidly connected to the third part ofthe Y-connector to permit gas from the single source to flow into thenebulizer to create the aerosolized medication that is delivered intothe main conduit body and to the patient through the patient interfaceconduit. The gas port has a first inner diameter and the gas inlet portof the nebulizer has a second inner diameter which is greater than thefirst inner diameter.

Further aspects and features of the exemplary aerosol inhalation systemdisclosed herein can be appreciated from the appended Figures andaccompanying written description.

BRIEF DESCRIPTION OF THE DRAWINGS FIGURES

The foregoing and other features of the present invention will be morereadily apparent from the following detailed description and drawings ofthe illustrative embodiments of the invention wherein like referencenumbers refer to similar elements and in which:

FIG. 1 is a perspective view of an accessory for use in an aerosolinhalation system according to a first embodiment;

FIG. 2 is a perspective view of an accessory for use in an aerosolinhalation system according to a second embodiment;

FIG. 3 is a partial cross-sectional view taken along the line 3-3 ofFIG. 1;

FIG. 4 is a partial cross-sectional view taken along the line 4-4 ofFIG. 1;

FIG. 5 is a partial cross-sectional view taken along the line 5-5 ofFIG. 1;

FIG. 6 is a side elevation view, in cross-section, of an accessory foruse in an aerosol inhalation system according to a third embodiment withthe parts thereof being exploded; and

FIG. 7 is a side elevation view, in cross-section, of the accessory ofFIG. 6 with the parts of the system of FIG. 6 being attached to oneanother.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Now turning to FIGS. 1 and 3-5 in which an accessory or interfaceelement 100 according to one exemplary embodiment and for use in anaerosol delivery system is illustrated. As described below, theaccessory 100 is intended for use with a nebulizer or an MDI or anotherpiece of aerosol inhalation equipment. The accessory 100 is defined by abody 110 that can be formed of any, number of different materials,including a plastic material or a metal. The accessory 100 isessentially a hollow body 110 that has a first end (inlet end) 112 andan opposing second end (outlet end) 114. The accessory 100 is intendedto act as a fluid connector in that it is fluidly attached to anotherpiece of equipment, such as a facemask, that is directly coupled to thepatients mouth, as well as being fluidly attached to an actuatabledevice that generates the aerosol particles (aerosolized medication)that are delivered to the patient.

In the illustrated embodiment, the body 110 has a main section 116 thatincludes a number of arms or feet that extend outwardly therefrom, withthe inlet end 112 being formed at the end of a first leg 120 that isformed at a right angle to the main section 116. The main section 116includes a second leg 130 that extends outwardly therefrom between thefirst leg 120 and the outlet end 114 and a third leg 140 that is locatedbetween tile outlet end 114 and the second leg 130. The third leg 140 islocated proximate the outlet end 114, while the second leg 130 is closerto the first leg 120. The first, second and third legs 120, 130, 140 arethus tubular structures that are in fluid communication with theinterior of the tubular main section 116 and are open at their oppositedistal ends to receive an object (such as a conduit or connector) or afluid, etc.

The main section 116 includes a fourth leg 150 that extends outwardlyfrom the main section 116 and is in fluid communication with theinterior of the main section 116. Like the other legs, the fourth leg150 is a tubular structure that is open at its distal end for anattachment to an object (conduit). In the illustrated embodiment, thefirst, second and third legs 120, 130, 140 extend outwardly from allunderside of the tubular main section 116, while the fourth lea 150extends outwardly from the opposite top side of the tubular main section116. The fourth leg 150 is located between the second and third legs130, 140.

The main section 116 is the part of the accessory 100 that is intendedto be connected to equipment that is placed over the patient's nose andmouth. Thus, the main section 116 (main conduit) is the principalpathway for fluid, such as air and the aerosol particles, to eitherenter the patient in the case of aerosol particles and air or to bedischarged from the patient as in the case of exhaled gases, such ascarbon dioxide.

The first leg 120 serves as a poll or connector for mating with a device200 that generates a gas flow that is intended to be breathed in by thepatient. For example, the device 200 can be in the form of a nebulizeror even an MDI or the like. In the illustrated embodiment, the device isin the form of a nebulizer 200 that is fluidly connected to a gas sourcevia a nebulizer conduit 215. The nebulizer 200 is fluidly and sealinglyconnected to the first leg 120 so that the gas and aerosolized particlesgenerated by the nebulizer 200 are delivered into the interior of themain section 116 of the accessory 100. Any number of techniques call beused to couple the nebulizer 200 to the first leg 120, such asthreadingly, snap-fittingly, functionally, etc., the two together.

In one embodiment, the accessory 100 is intended for use with anebulizer, generally indicated at 200, and therefore includes a holding,chamber 300 into which the aerosol particles can be stored prior to thepatient inhaling. The holding chamber 300 is preferably formed as amember that is collapsible and expandable depending upon whether gas isbeing delivered thereto or being evacuated therefrom. The holdingchamber 300 thus can have a number of different structures that have avariable dimension, such as a variable length or a variable width. Inone embodiment, the holding chamber 300 is defined by a bellows-typestructure that can either expand or collapse/constrict depending uponthe force applied. As with other accessories of this type, the holdingchamber 300 is intended to receive and store the aerosol particles priorto the patient inhaling them by means of the accessory 100 and thefacemask.

In the illustrated embodiment, the holding chamber 300 is in the form ofan expandable/collapsible bag (reservoir bag) or similar type structure.According to one aspect of the present invention, the holding chamber300 is in the form of a bi-furcated bag or the like 310 as shown inFIG. 1. More specifically, the bag 310 is bi-furcated and has twoindependent distinct compartments, namely a first compartment 320 and asecond compartment 330. Since the two compartments 320, 330 are distinctfrom one another (no fluid communication therebetween) the bag 310 has afirst port 340 that forms an entrance and is in fluid communication withthe first compartment 320, as well as a second port 350 that forms allentrance and is in fluid communication the second compartment 330. Aseparating wall or membrane 360 is formed as part of the bag 310 andserves to divide the bag 310 into the first and second compartments 320,330. The body of the bag 310, as well as the separating wall 360, ispreferable formed of a flexible material, such as a fabric that permitsthe bag 310 to either expand as when fluid enters the bag 310 orcontract (collapse) as when the fluid is evacuated from the bag 310. Thefirst port 340 is formed on one side of the separating wall 360, whilethe second port 350 is formed on the other side of the separating wall360. Both the first and second ports 340, 350 are typically defined by ahollow stem or boss.

The first port 340 includes a complementary fastening feature thatpermits it to be sealingly attached to the third leg 140 of theaccessory 100, and similarly, the second port 350 includes acomplementary fastening feature that permits it to be sealingly attachedto the second leg 130. For example, the first and second fasteningfeatures can be in the form of threads that mate with complementarythreads that are part of the legs 140, 130, respectively. Otherfastening, means, such as locking means or mechanical fits, such as africtional fit, can likewise be used so long as the accessory 100, andin particular, the second and third legs 130, 140, are sealinglyattached to the bag 310. While, the fastening features can be in theform of threads, it still be appreciated that in many applications andembodiments, the third and second legs 140, 130 and the first and secondports 340, 350 simply mate with one another via a frictional interfacefit between two complementary stems.

The first port 340 of the bag 310 also preferably includes a gas inletport 342 that extends outwardly therefrom and is constructed to attachto a gas source 370. More specifically, the gas inlet port 342 is influid communication with and provides an entrance into the first port340 and is in the form of a tubular structure that has a distal end 344.The end 344 is meant to be attached to the gas source 370 by any numberof techniques, including using a gas conduit, such as tubing or thelike, that extends from the gas source 370 to the gas inlet port 342.The gas source 370 is preferably connected to a control system orregulator or the like that permits the flow rate of the gas source 370to be carefully controlled and varied by means, such as valve assembliesand the like that are associated therewith (e.g., valve assembly withinthe gas conduit).

The gas source 370 can hold any number of different types of gases thatare intended for inhalation by the patient through the accessory 100.

The accessory 100 includes a number of different valve assemblies thatare positioned within the body 110. More specifically, a first valveassembly 400 is disposed within the open second end 114 of the mainsection 116 and in the illustrated embodiment the first valve assembly400 functions as an exhalation valve. The first valve assembly 400includes a valve element 402 which is positionable between an openposition and a closed position and which can be any number of differenttypes of valve structures so long as they function in the intendedmanner and provide the desired results. The valve 402 typically seatsagainst a valve seat 404 that is formed at the second end 114 when thevalve 402 is closed. The illustrated valve 402 is a one-way flap valvethat presses against the valve seat 404 on inhalation and completelyoccludes the open second end 114 to prevent any room air entrainment(i.e., not allowing, the air from the atmosphere to enter into the mainsection 116 on inhalation). On exhalation, the flap valve 402 moves awayfrom the flap valve seat 404 for the air exhaled by the patient toescape into the atmosphere from the main section 116 by flowing throughthe fourth leg 150 from a mask or the like and then through the mainsection 116 and through the opening formed at the second end 104. Theopen second end 104 is the only means for the exhaled air to escape aswill be appreciated below since the four legs 120, 130, 140, 150 areconnected to devices, are capped or otherwise not open.

A second valve assembly 410 is provided and functions as an inhalationvalve in that the valve moves between an open position and a closedposition depending upon whether the patient is inhaling or exhaling. Thesecond valve assembly 410 is disposed within the body 110 and inparticular, the second valve assembly 410 is disposed within the mainsection 116 at a location between the second leg 130 and the fourth leg150 such that when the second valve assembly 410 is in an open position,fluid can flow from both the first leg 110 and the nebulizer 200, aswell as from the second leg 130 and the second compartment 330 of thebag 310, and into the fourth leg 150 where it can flow into thepatient's mask and into the patient's respiratory system.

The second valve assembly 410 includes a valve element 412 that can beany number of different types of valve structures so long as theyfunction in the intended manner and provide the desired results. Asshown in FIG. 5, the valve 412 typically seats against a valve seat 414that is formed within the main section 116 when the valve 412 is closed.The illustrated valise 412 is a one-way flap valve that presses againstthe valve seat 414 on exhalation and completely occludes the mainsection 116 to prevent any exhaled air to flow from the mask and fourthleg 150 and into either the second compartment 330 of the bag 310 or thefirst leg 120. On inhalation, the flap valve 412 moves away from theflap valve seat 414 to permit the gas from the nebulizer 200 and/or gasstored in the second compartment 330 of the bag 310 to flow into andthrough the main section 116 and into the fourth leg 150 where it flowsinto the mask to the patient.

As in FIG. 4, a third valve assembly 420 is provided and is disposed inthe third leg 140 or it can be provided in the stem that defines thefirst port 340 that is associated with the bag 310. The third valveassembly 420 functions as an inhalation valve in that the valve movesbetween an open position and a closed position depending upon whetherthe patient is inhaling or exhaling.

The third valve assembly 420 includes a valve element 422 that can beany number of different types of valve structures so long as theyfunction in the intended manner and provide the desired results. Thevalve 422 typically seats against a valve seat 424 that is formed withineither the third leg 140 or first port 340 when the valve 422 is closed.The illustrated valve 422 is a one-way flap valve that presses againstthe valve seat 424 on exhalation and completely occludes the third leg140 or first port 340 to prevent any exhaled air to flow from the maskand fourth leg 150 and into either the first compartment 320 of the bag310. On inhalation, the flap valve 422 moves away from the flap valveseat 424 to permit the gas from the first compartment 320 of the bag 310to flow into and through the main section 116 and into the fourth leg150 where it flows into the mask to the patient.

While the two compartments 320, 330 of the bag 310 are illustrated ashaving equal or about equal volumes it will be appreciated that the bag310 can be constructed so that one of the compartments 320, 330 has agreater volume. For example, the first compartment 320 that serves asthe nebulizer holding compartment can have a greater volume than thesecond compartment 330 which receives the supplemental gas to backup thenebulized medication holding chamber.

The first leg 120 is intended to be fluidly attached to the device thatgenerates the aerosol particles (medication) that is delivered to thepatient and preferably, as illustrated, the first leg 120 is fluidlyconnected to the nebulizer 200. More specifically, a connector 212 of aconduit (tube) 210 of the nebulizer 200 is sealingly attached to thefirst leg 120 so that tile nebulized medication is delivered thoroughlythe conduit 210 and into the interior of the first leg 120 and when thesecond valve element 412 is open, the nebulized medication (aerosolparticles) travels the length through the first leg 120 and a portion ofthe main section 516 and through the opening defined by the valve seat414 and into the fourth leg 150 and then into the equipment (facemask)that delivers the medication to the patient. This is the sequence ofevents when the patient inhales. Conversely, when the patient exhales,the second valve element 412 closes; however, the nebulizer 200continues to deliver the nebulized medication through the first leg 120into the interior of the main section 116. Since the second valveelement 412 is closed when the patient exhales prior to the nextinhalation the nebulized medication can not flow past the valve assembly410 and into the fourth leg 150 but instead flows through the second leg130 through the second port 350 and into the second compartment 330 ofthe bag 310.

The second compartment 330 of the bag 310 is therefore intended to actas a main reservoir bag in that the second compartment 330 receives andholds the nebulized medication until the patient inhales. The secondcompartment 330 of the bag 310 thus expands until the patient inhales atwhich time the second valve element 412 opens and the inhalation of thepatient draws the nebulized medication out of the second compartment 330into the main section 116 and then into the fourth leg 150 where it isdelivered to the patient.

There are some circumstances where an insufficient amount of nebulizedmedication is present in the second compartment 330 of the bag 310. Thismay result because the flow rate of the nebulizer 200 is insufficientfor the patient as when the patient has a greater body weight than theflow rate setting of the nebulizer 200. When this does occur, thepatient experiences a very uncomfortable feeling in that the patientwill experience an insufficient air flow to the lungs and therefore willbegin to breathe more deeply and rapidly. In other words, the patientmay begin feeling as though they need to gasp for air to breathe.

The present invention overcomes such potential deficiency in air flow tothe patient by providing the first compartment 320 in the bag 310 whichacts as a supplemental air source for the patient due to the firstcompartment 320 being attached to a supplemental gas source, generallyindicated at 370. Preferably, the gas source 370 connects to the sternof the first port 340 as shown in the figures; however, it is possiblefor the gas source 370 to be directly connected to the first compartment320 of the bag 310. In any event, the gas source 370 is directly andfluidly connected to the first compartment 320 and therefore, the gas isdelivered into the first compartment 320. As with the flow of nebulizedmedication into the second compartment 330, the flow of the gas source370 into the first compartment 320 causes the first compartment 320 toexpand as the bag 310 is filled with gas.

It will be appreciated that the gas source 370 serves as a supplementalgas since gas stored in the first compartment 320 is in selective fluidcommunication with the main section 116 and therefore, can flow to thepatient under certain circumstances as discussed below. In other words,if there is insufficient gas in the form of nebulized gas in the secondcompartment 330, when the patient inhales, then the patient will notexperience the above described breathing problems since the firstcompartment 320 is open to the patient through, the main section 116 andtherefore the patient can inhale the supplemental gas that is present inthe first compartment 320 to make up for any shortfall in gas in thesecond compartment 330.

The gas source 370 typically has an associated valve assembly (notshown) that is external to the system and is typically at the gas source370 for controlling the flow rate of the gas source 370 into the firstcompartment 320. The valve assembly is preferably an adjustable valvethat controls the flow rate of the supplemental gas into the firstcompartment 320. Any number of different valve mechanisms are suitablefor this type of application and typically include an adjustable part,such as a dial, that permits the physician to easily alter and changethe flow characteristics. For example, the valve mechanism can includean adjustable member that when manipulated either sequentially closes oropens the opening, formed in the conduit that delivers the supplementalgas to the first compartment 320.

Thus, the physician can initially set the valve at one setting which thephysician believes will provide a sufficient supplemental gas flow intothe first compartment 320 based on the physicians past experiences andbased on certain characteristics of the patient, such as the size andweight of the patient. For example, when the patient is a large adult oreven a large child, the flow rate of the nebulized medication into thesecond compartment 330, even when it is set at a maximum flow rate, maynot be sufficient and therefore, this could result in the patientreceiving a low level of air and feeling the above noted discomfort. Thegas source 370 thus supplements the gas flow of the nebulizer 200 andmakes up for any deficiency so that the patient breaths smoothlythroughout the procedure.

When setting the valve, the physician will keep in mind that it may notbe desirable to set the flow rate of the supplemental gas at too high avalue since this will result in the first bag compartment 320 expandingand also, results in the supplemental gas source 370 nixing with thenebulized medication as the patient inhales, thereby causing a decreasein the inhaled concentration of the medication. As mentioned before, itis desirable to try to keep as fixed as possible the concentration ofthe inhaled medication. Since the first compartment 320 is fluidlyconnected to the main section 116 via the third leg 140 and is fluidlyconnected to the first valve assembly 400, any excess build up ofsupplemental gas in the first compartment 320 can be vented through thefirst valve 402 each time the patient exhales since the second valveassembly 410 closes when the patient exhales and the supplemental gascan not flow past the second valve assembly 410 toward the other legsand the second compartment 330 of the bag 310.

In the event that the initial setting of the valve is not optimal inthat the too much supplemental gas is being delivered to the first bagcompartment 320 or too little supplemental gas is being delivered to thefirst bag compartment 320, the physician simply needs to make thenecessary adjustment to the valve to either immediately reduce orincrease, respectively, the supplemental gas flow into the first bagcompartment 320. This can be done by simply turning or otherwisemanipulating the valve. It is also very easy for the physician todetermine whether the flow rate of the supplemental gas source 370 isoptimal since the physician can observe the bag 310 and moreparticularly, can observe whether either the first bag compartment 320,the second compartment 330 or both compartments 320, 330 appear to beexcessively collapsed (thus indicating an increase in flow rate isneeded) or excessively expanded or extended (thus indicating a decreasein flow rate is needed). The physician can simply and immediately alterthe flow rate and thus, the accessory 100 is tailored to be used with awhole range of different types of patients, from small infants up tolarge adults.

A supplemental gas valve assembly is preferably provided for controllingthe flow of the supplemental gas out of the first compartment 320 andinto the third leg 140 and more particularly, to permit flow of thesupplemental gas from the first bag compartment 320 into the third leg140, through the main section 116 and ultimately to the patient when thepatient inhales and conversely, preventing the flow of supplemental gasfrom the first bag compartment 320 into the third leg 140 when thepatient exhales. It will also be appreciated that when valve assemblycloses during exhalation, the exhaled air that includes waste gases isnot permitted to flow into the first bag compartment 320 where it couldthen be drawn into the patient at the next annihilation movement of thepatient.

Now referring to FIG. 2 in which another embodiment of an accessory 101is illustrated. The accessory 101 is similar to the accessory 100 andtherefore, like elements are numbered alike. In the accessory 101, thefirst leg 120 no longer is formed at one end of the main section 116 butrather is formed in the middle of the main section between the fourthleg 150 and the second leg 130 which is located closer to one end of themain section 116. In this design, the first leg 120 is closer to thefourth leg 150 and since the first leg 120 is still fluidly connected tothe nebulizer 200, the length of the gas flow path from the nebulizer200 to the face mask is less in this embodiment than in the embodimentof FIG. 1 due to the relative positions of the first and fourth legs120, 150.

Since the first leg 120 is not formed at the end of the main section 116in this embodiment, the main section 116 has an open end 117 and aclosed end 119. The second leg 130 is located proximate the open end117.

As shown the first leg 120 is disposed between the second valve assembly410 and the second leg 130 and in particular, the first leg 120communicates with the interior of the main section 116 at a locationthat is near the second valve element 412. It will be appreciated thatin this embodiment, the nebulizer 200 is located in front of/downstreamfrom the gas flow from the second compartment 330 of the bag 310 and thepresent applicants have discovered that the placement of the nebulizer200 in this location results in improved performance and improved drugdelivery since the aerosolized medication is located closer to the facemask as measured along the gas flow path. In addition, this location forthe nebulizer 200 permits the gas flow from the second compartment 330of the bag 110 to assist in carrying the aerosolized medication to thefourth leg 150 and into the patient's mask or the like. In other words,the gas flow from the second compartment 330 acts to entrain theaerosolized medication that is flowing, through the first leg 120 fromthe nebulizer 200.

The first valve 400 is located in the open end 117 of the section 116.

The operation of the components is the same in this embodiment as in theother embodiments. For example, the valve assemblies 400, 410, 420operate the same or similar in both embodiments. The first leg 120 ispositioned close to the second valve assembly 410 such that once thevalve element 412 opens upon inhalation, the gas and aerosolizedmedication from the nebulizer 200 flows through the valve element 412and into the fourth leg 150 to the patient.

It will also be appreciated that in each of the embodiments of FIGS. 1and 2, the first leg 120 can be capped or otherwise sealed as whennebulizer 200 is not used with the respective accessory. In this design,the bag 310 can serve as a means for delivering a gas, such as oxygen orhelix, etc., to the patient. In particular; gas source 370 provides gasthat is routed through the first compartment 320 of the bag 310 and intothe main section 116 and then into the fourth leg 150 to the face mask.

Referring now to FIGS. 6-7 in which yet another embodiment of thepresent invention is illustrated. In this embodiment, an accessory 500is illustrated and is similar in construction to the accessories 100 and300; however, as described below, there are several key differences.

As with the other accessories, the accessory 500 is intended for usewith a nebulizer or an MDI or another piece of aerosol inhalationequipment. The accessory 500 is defined by a body 510 that can be formedof a number of different materials, including plastics or even metals.The accessory 500 is essentially a hollow body 510 that has a first end512 and an opposite closed second end 514. The accessory 500 is intendedto act as a fluid connector in that it is fluidly connected to anotherpiece of equipment, such as a facemask, that is directly coupled to thepatient's mouth, as well as being fluidly attached to an actuatabledevice that generates the aerosol particles (aerosolized medication)that are delivered to the patient.

In the illustrated embodiment, the body 510 has a main section 520 thatincludes a number of arms or feet that extend outwardly therefrom. Morespecifically, a first leg 530 is formed at or proximate the first end512 of the body 510, a second leg 540 is formed in an intermediateregion of the body 510 and a third leg 550 is formed at or proximate thesecond end 514. In other words, the second leg 540 is formed between thefirst and third legs 530, 550. The first, second and third legs 530,540, 550 are tubular structures that are in fluid communication with theinterior of the tubular main section 520 and are open at their oppositedistal ends to receive an object (such as a conduit or connector, etc.)or a fluid, etc.

The main section 520 also includes a fourth leg 560 that extendsoutwardly from the main section 520 and is also in fluid communicationwith the interior of the main section 520. Like the other legs, thefourth leg 560 is a tubular structure that is open at its distal end forattachment to an object, such as a mask or mouthpiece or the like,generally indicated at 561. In the illustrated embodiment, the first,second and third legs 530, 540, 550 extend from an underside of the mainsection 520, while the fourth leg 560 extends front a top side of themain section; however, this is merely an exemplary arrangement, and therelative positions of the legs can be varied, including having the legsbe disposed at less than 90 degrees from one another. The fourth leg 560is located between the first and second legs 530, 540.

The main section 520 is part of an accessory that is intended to beconnected to equipment that is placed over the patient's nose and mouth,thus, the main section 520 (main conduit) is the principal pathway forfluid to either enter the patient in the case of aerosol particles andair (or other fluid) or to be discharged from the patient as in the caseof exhaled gases, such as carbon dioxide.

Unlike the embodiments shown in FIGS. 1 and 2, the accessory 500 isintended to be connected to a single gas source, as opposed to twoseparate gas sources. More specifically, the second end 514 is a closedend of the main section and the third leg 550 serves as a port orconnector for mating with a device 600 that generates a gas flow that isintended to be breathed in by the patient. For example, the device 600can be in the form of a nebulizer or even an MDI or the like. In theillustrated embodiments the device 600 is shown exploded from the mainsection 520 and is in the form of a nebulizer body 610 that includes themedication be to be delivered and has a leg 612 that is sized and shapedto be received into the third leg 550. The leg 612 is thus a hollowtubular structure that is matingly and frictionally received and heldwithin the third less 550 when it is opened. FIG. 7 shows a removablecap 701 disposed within the third leg 550; however, when the nebulizer600 is to be connected to the main section 520, the cap 701 is simplyremoved from the third leg 550 so as to fully open up the third leg 550.The nebulizer 600 is thus slidingly inserted into the third leg 550 andcan later be removed therefrom.

In addition to having a compartment for holding the medication to beaerosolized, the nebulizer body 610 has a conduit 620 that is intendedto be fluidly connected to a source of gas for creating the aerosolizedmedication. For example, a gas conduit (tube) can be connected to a fleeend of the conduit 620 for providing gas to the nebulizer 600.

The cap 701 can be attached to the third leg 550 by means of a flexiblestrap 703 or the like so that when the cap 701 is removed from the thirdleg 550, the cap 701 can simply hang from the third leg 550, therebyreducing the chances that it might be misplaced, etc. The cap 701 has anipple 705 or the like that is a hollow conduit that includes a bore orthorough hole that extends completely thorough the cap 701, therebypermitting fluid communication between the exterior and the interior ofthe third leg 550, and thus, the interior of the main section 520.

As with the other embodiments, the accessory 500 is intended for usewith the nebulizer 600 and therefore includes a holding chamber 700 intowhich the aerosol particles can be stored prior to the patient inhaling.The holding chamber 700 is preferably formed as a member that iscollapsible and expandable depending upon whether gas is being deliveredthereto or being evacuated therefrom. The holding chamber 700 thus canhave a number of different structures that have a variable dimensionssuch as a variable length or a variable width. In one embodiment theholding chamber 700 is defined by a bellows-type structure that caneither expand or collapse/constrict depending upon the force applied. Aswith other accessories of this type, the holding chamber 700 is intendedto receive and store the aerosol particles prior to the patient inhalingthem by means of the accessory 500 and the facemask.

In the illustrated embodiment, the holding chamber 700 is in the form ofan expandable/collapsible bag (reservoir bag) or similar type structure.According to one aspect of the present invention, the holding chamber700 is in the form of a bi-furcated bag or tile like 710 as shown inFIG. 6. More specifically, the bag 710 is bi-furcated and has twoindependent distinct compartments namely a first compartment 720 and asecond compartment 730. Since the two compartments 720, 730 are distinctfrom one another (no fluid communication therebetween), the bag 710 hasa first connector 740 that forms all entrance and is in fluidcommunication with the first compartment 720, as well as a secondconnector 750 that forms an entrance and is in fluid communication thesecond compartment 730. A separating wall or membrane 760 is formed aspart of the bag 710 and serves to divide the ban 710 into the first andsecond compartments 720, 730. The body of the bag 710, as well as theseparating wall 760, is preferable formed of a flexible material, suchas a fabric that permits the bag 710 to either expand as when fluidenters the bag 710 or contract (collapse) as when the fluid is evacuatedfrom the bag 710. The first connector 740 is formed on one side of theseparating wall 760, while the second connector 750 is formed on theother side of the separating wall 760. Both the first and secondconnector 740, 750 are typically defined by a hollow stem or boss.

The first connector 740 includes a complementary fastening feature thatpermits it to be sealingly attached to the first leg 530 of theaccessory 500, and similarly, the second connector 750 includes acomplementary fastening feature that permits it to be sealingly attachedto the second leg 540. For examples the first and second fasteningfeatures can be in the form of threads that mate with complementarythreads that are part of the legs 530, 540, respectively. Otherfastening means, such as locking means or mechanical fits, such as africtional fit, can likewise be used so long as the accessory 500, andin particular, the second and third legs 530, 540, are sealinglyattached to the bag 710. While, the fastening features can be in theform of threads, it will be appreciated that in many applications andembodiments, the third and second legs 530, 540 and the first and secondconnectors 740, 750 simply mate with one another via a frictionalinterface fit between two complementary stems.

The first con hector 740 of the bag 710 also preferably includes a gasinlet port 742 that extends outwardly therefrom and is constructed toattach to a gas source. More specifically, the gas inlet port 742 is influid communication with and provides an entrance into the firstconnector 740 and is in the form of a tubular structure that has adistal end 744. The end 744 is meant to be attached to the gas source byany number of techniques, including using a gas conduit, such as tubingor the like, that extends from the gas source to the gas inlet port 742.The gas source is preferably connected to a control system or regulatoror the like that permits the flow rate of the gas source to be carefullycontrolled and varied by means, such as valve assemblies and the likethat are associated therewith (e.g., valve assembly within the gasconduit).

The gas source can hold any number of different types of gases that areintended for inhalation by the patient through the accessory 500.

In addition, the first leg 530 can contain a supplemental gas inlet portor connector 751 that extends outwardly therefrom and can be fluidlyattached to a supplemental gas source. The gas inlet port 751 is formedso that it is above the first connector 740 when the first connector 740is inserted into the first leg 530 so that the gas inlet port 751 doesnot interfere with the reception of the first connector 740 into thefirst leg 530.

The second connector 750 is similar to the first connector 740 and is inthe form of a tubular connector that is both sized and shaped to fitintimately within the second leg 540. For example, the second connector750 can be frictionally fit into and held within the second leg 540 asby slidingly engaging the second connector 750 within the second leg540. The lengths of the first and second connectors 740, 750 arepreferably the same.

The accessory 500 includes a number of different valve assemblies thatare positioned within the body 510. More specifically, a first valveassembly 800 is disposed within the open first end 512 of the mainsection 520 and in the illustrated embodiment, the first valve assembly800 functions as an exhalation valve. The first valve assembly 800includes a valve element 802 which is positionable between an openposition and a closed position and which can be any number of differenttypes of valve structures so long as they function in the intendedmanner and provide the desired results. The valve 802 typically seatsagainst a valve seat that is formed at the first end 512 when the valve802 is closed, the illustrated valve 802 is a one-way flap valve thatpresses against the valve seat on inhalation and completely occludes theopen first end 512 to prevent any room air entrainment (i.e., notallowing the air from the atmosphere to enter into the main section 520on inhalation). On exhalation, the flap valve 802 moves away from theflap valve seat for the air exhaled by the patient to escape into theatmosphere from the main section 520 by flowing through the fourth leg560 from a mask or the like and then through the main section 520 andthrough the opening formed at the first end 512. The open first end 512is the only means for the exhaled air to escape as will be appreciatedbelow.

A second valve assembly 810 is provided and functions as a firstinhalation valve in that the valve moves between an open position and aclosed position depending upon whether the patient is inhaling orexhaling. The second valve assembly 810 is disposed within the first leg530 when the holding chamber is attached thereto and in particular, thesecond valve assembly 810 includes a valve element 812 that is disposedat the free distal end of the connector 740.

The second valve assembly 810 includes a valve element 812 that can beany number of different types of valve structures so long as theyfunction in the intended manner and provide the desired results. Thevalve 812 typically seats against a valve seat that is formed at thedistal end of the connector 740. The illustrated valve 812 is a one-wayflap valve that presses against the valve seat on exhalation andcompletely occludes the first leg 530 to prevent any exhaled air to flowfrom the mask through the main section 520 and into the firstcompartment 710. The valve element 612 is thus positioned so that thegas inlet port 742 is disposed between the valve element 812 and thefirst compartment 710. Thus, the closing of the valve element 812prevents exhaled gas from flowing into the gas inlet poll 742.

It will be appreciated that instead of incorporating the valve element812 into the connector 740, the valve element 812 can be directlyincorporated into the first leg 530 such that it still selectivelypermits fluid flow from the first compartment 710 and from the gas inletport 742.

The valve element 812 is thus positioned so that the gas inlet port 742is disposed between the valve element 812 and the first compartment 710.Thus, the closing of the valve element 812 prevents exhaled gas fromflowing, into the gas inlet port 742.

A third valve assembly 820 is provided and functions as a secondinhalation valve in that the valve moves between an open position and aclosed position depending upon whether the patient is inhaling orexhaling. The third valve assembly 820 is disposed within the mainsection 520 and in particular, the third valve assembly 820 is disposedwithin the main section 520 between the first and second legs 530, 540.In addition, the third valve assembly 820 is disposed between the fourthleg 560 and the second leg 540.

The third valve assembly 820 includes a valve element 822 that can beany number of different types of valve structures so long as theyfunction in the intended manner and provide the desired results. Thevalve 822 typically seats against a valve seat 824 that is formed withinthe main section 520. The illustrated valve 822 is a one-way flap valvethat presses against the valve seat 824 on exhalation and completelyoccludes the main section 530 to prevent any exhaled air to flow fromthe mask through the main section 520 and into the first compartment710.

Both the first and second inhalation valves 812, 822 close when thepatient exhales and conversely open when the patient inhales. Thus, whenthe patient exhales and the valves 812, 822 close, the exhaled gastravels down the fourth leg 560 into the main section 520; however noneof the first, second and third legs 530, 540, 550 are accessible andtherefore, the exhaled gas must flow to the exhalation valve 802, whichis open and thus, the exhaled gas flows out of the main section 820.

While the two compartments 720, 730 of the bag 710 are illustrated ashaving equal or about equal volumes, it will be appreciated that the bag710 can be constructed so that one of the compartments 720, 730 has agreater volume. For example, the first compartment 720 that serves asthe nebulizer holding compartment can have a greater volume than thesecond compartment 730 which receives the supplemental gas to backuptile nebulized medication holding chamber.

In this embodiment, there is a single main gas source as opposed to thetwo gas sources of the previous embodiments. A single main gas source900 is provided and a first conduit section 910 is connected at a firstend 912 to the gas source 900, while an opposite second end 914 isconnected to a conduit adapter or connector 920. The connector 920 is aY connector in that it has a first leg 922 that is connected to thesecond end 914 of the conduit 910, as well as second and third legs 924,926, respectively. Fluid flow (gas from source 900) is thus deliveredinto the first leg 922 and then split into two flow paths, namely, thosedefined by the second and third legs 924, 926. A second conduit section930 is connected at a first end 932 to the second leg 924 and a separatethird conduit section 940 is connected at a first end 942 to the thirdleg 926. An opposite second end 934 of the second conduit section 900 isconnected to the gas inlet port 742 to deliver (as from the source 900into the first compartment 710 and/or into the main section 520 bytraveling through the first leg 530. An opposite second end 944 of thethird conduit section 940 is connected to either the nipple 705 that ispart of the cap 701 or the conduit 620 of the nebulizer body 610depending upon whether the nebulizer 600 is installed in the third leg550 or whether the cap 701 is installed in the third leg 550. In eitherinstance, gas flows through the second conduit section 930 and into thethird leg 530. When it is desired to deliver aerosolized medication tothe patient, then the nebulizer 600 is installed in the third leg 550and the second conduit section 930 is connected to the conduit 620 topermit gas to flow from main gas source 900 to the nebulizer 600 wherethe medication is aerosolized.

The use of a single main gas source 900 compared to two separate gassources (as in the other embodiments) provides a number of advantages.First, the use of a single source is more economical and simpler indesign since only one supply of gas is needed. Consequently, less spaceis consumed since only one gas tank is needed. In addition, since onlyone gas is used, the flow rates and the formulations for the patient canbe more easily controlled and monitored.

When operating the accessory 500 with the nebulizer 600, the nebulizer600 is inserted into the third leg 550. The second leg 540 remainscapped for most applications and the gas input (conduit 620) of thenebulizer 600 becomes the third port of the accessory 600. The secondand third legs 540, 550 are constructed as gas inlet ports that utilizegas tubing.

In accordance with one aspect of the present invention the dimensions ofthe gas inlet port 742 and the conduit 620 of the nebulizer 600 arecarefully selected to optimize the performance of the nebulizer 600. Inparticular, the gas inlet port 742 is constructed so that it hasdimensions (e.g., diameter) less than the dimensions of the conduit 620of the nebulizer 600. For example, the spray hole for commerciallyavailable nebulizers 600 ranges from about 0.022 inches to about 0.025inches. The resultant flows in the tubing (port 742 and conduit 620) areas follows when using 15 LPM (liters per minute) Ox (the maximalmeasurable flow for commercially available flowmeters for air andoxygen). For example, the diameter for port 742 is identified as P1 andcan have a diameter of between about 0.020 inches and 0.025 inches andthe diameter for conduit 620 (nebulizer spray hole) is identified as P3and can have a diameter of between about 0.022 inches and 0.025 inches.However, in the various exemplary embodiments, the size of the port 742is less than the size of the conduit 620 (nebulizer spray hole). Theratio for the two openings determines the ratio of the two gas flowsthrough the port 742 and conduit 620.

If P1>P3, then more than half of the flow will go through the gas tubingto the gas inlet port 742. The nebulizer 1100 will receive less than 7.5LPM of flow. If P1 is substantially greater than P3, then the flow tothe nebulizer 1100 will be much less than 7.5 LPM. Since most singletreatment nebulizers require 8 LPM to 12 LPM to work optimally, thiscondition is less than ideal. If P1=P3, then half of the flow will gothrough the tubing to the port 742. The nebulizer 1100 will receive 7.5LPM of flow. Since most single treatment nebulizers require 8 LPM to 12LPM to work optimally, this condition is less than ideal although thenebulizer 600 will be useable.

If P1<P3, then more than half of the flow will go through the tubing toport (conduit) 620. This nebulizer receive more than 7.5 LPM of low.Since most single treatment nebulizers 600 require 8 LPM to 12 LPM towork optimally, this condition is ideal as long as P1>P3 but not when P1is substantially greater than P3 since the flow to the nebulizer willapproach 15 LPM and the tubing disconnect from port 620 due to backpressure. For the case, where P1>P3 within about 20%, we observe thatthe nebulizer 600 will see approximately 20% more than half the flow.Thus, the nebulizer 600 would receive a flow of about 9 LPM which iswithin most nebulizer optimal operating parameters.

Thus, for the given total flow to the system, the ratios of the flowsthrough P1 and P3 are dependent on the ratios of the (r⁴) of the twoholes, where r is the radius of the opening. Thus, the flow through port742/the flow through port 620 is equal or approximately equal to[(radius port 742)⁴]/[(radius port 620)⁴]. The spray hole (conduit 620)for commercially available nebulizers range from about 0.022 inches toabout 0.025 inches. So, if port 742 has a radius of about 0.020 inches,this allows for flow ranging from 8.5 LPM to about 11 LPM. It will alsobe appreciated that the above optimization techniques for the sizing ofthe ports 742, 620 is not limited to the situation where the (as is air,but instead, other gases, such as helix which is very much less dense,can be used. If the port 742 had the same dimensions as the conduit 620,the greater part of the gas would flow through port 742 andconsequently, the nebulizer 600 would not get sufficient gas flow. Sincethe gas is lighter than Ox, even less gas would go to the nebulizer 600.When helix is used, the flow rate can be set at 16.5 LPM using a flowmeter designed for use with helix. Since helix gas requires a higherflow rate than oxygen to nebulize the same dose output, higher flowshave to be set up with the helix flow meters. Otherwise, correctionfactors have to be used in order to determine the correct reading thatcorresponds to 16.5 LPM. Flows of 10 LPM to 14 LPM are recommended fornebulizer operation.

Flows through the second and third conduit sections 930, 940 to theports 742, 620, respectively, determine the resultant flow to thenebulizer 600. This is in part due to ratios of the hole sizes statedabove. Once the flow window for port 610 (the nebulizer 600) has beendetermined to be within about 8 LPM to about 12 LPM, optimal operationfor mobilization is assured. Port 742 can be used to dilute a given gasused (such as oxygen or premixed helix, through ports 742, 620). This isdone by using the original gas with the Y tubing and then opening port742 to outside air or by using a second gas source to deliver air at afixed rate. Alternatively, another gas could be used through port 742and in one embodiment, anesthesia gas can be introduced into the port742.

It will be appreciated that the above dimensions are merely exemplaryand the components can have dimensions that lie outside the above rangesso long as the desired results, as discussed above, are achieved.

Having described embodiments of the invention with reference to theaccompanying drawings it is to be understood that the invention is notlimited to those precise embodiments, and that various changes andmodifications may be effected therein by one skilled in the art withoutdeparting from the scope or spirit of the invention as defined in theappended claims.

1. An aerosol inhalation system comprising: a single source of gas; aY-connector having a first port in fluid communication with the gassource via a first conduit and second and third ports; an accessoryhaving a main conduit body that includes a first leg, a second leg, anda third leg, all of which are in fluid communication with the mainconduit section, the first leg being fluidly connected to the secondport of the Y-connector via a second conduit to permit gas from thesingle source to flow through the first leg, the accessory including apatient interface conduit that is adapted to deliver aerosolizedmedication to a mouth of the patient; a nebulizer sealingly andremovably disposed within the third leg, the nebulizer including a gasinlet port that is fluidly connected to the third port of theY-connector to permit gas from the single source to flow into thenebulizer to create the aerosolized medication that is delivered intothe main conduit body and to the patient through the patient interfaceconduit; and a holding chamber having a first compartment and a secondcompartment separated from the first compartment, with the firstcompartment being sealingly and fluidly coupled to the first leg and thesecond compartment being sealingly and fluidly coupled to the secondleg, wherein the holding chamber is defined by a reservoir bag with thefirst and second compartments defined therein and separated from oneanother by a bi-furcating wall, the reservoir bag being formed of anexpandable/collapsible material.
 2. The system of claim 1, furtherincluding: an arrangement of valves such that when the patient exhales,the first, second and third legs are sealingly closed off from thepatient interface conduit resulting in exhaled air being delivered to afirst end of the main conduit body that is selectively open when thepatient exhales and conversely, when the patient inhales, the first,second and third legs are opened to the main conduit body resulting inthe aerosolized medication being delivered through the main conduit bodyto the patient interface conduit and to the patient.
 3. The accessory ofclaim 2, wherein the arrangement of valves includes an exhalation valvethat is disposed at the first end of the main conduit body, theexhalation valve moving between an open position when the patientexhales, thereby opening the main conduit body to atmosphere and aclosed position when the patient inhales.
 4. The accessory of claim 3,wherein the exhalation valve comprises a one way valve.
 5. The accessoryof claim 2, wherein the arrangement of valves includes a firstinhalation valve that is in communication with the first leg and asecond inhalation valve that is disposed within the main conduit bodybetween the first and second legs, each inhalation valve moving betweenan open position when the patient inhales, thereby opening at least oneof the first, second and third legs to the patient interface conduit anda closed position when the patient exhales.
 6. The accessory of claim 5,wherein each of the inhalation valves comprises a one way valve.
 7. Theaccessory of claim 2, wherein the holding chamber has a supplementalfluid port associated therewith which is in fluid communication with thefirst leg for introducing a gas into the first leg and into the firstcompartment of the holding chamber, the supplemental fluid port having afirst inner diameter and the gas inlet port of the nebulizer has asecond inner diameter which is greater than the first inner diameter. 8.The accessory of claim 7, wherein the second inner diameter is at least10% greater than the first inner diameter.
 9. The accessory of claim 7,wherein the second inner diameter is between about 10% to about 20%greater than the first inner diameter.
 10. The accessory of claim 7,wherein the gas is oxygen and the first and second inner diameters areselected so that the nebulizer receives a flow rate between about 8 LPM(liters per minute) to about 12 LPM.
 11. The accessory of claim 7,wherein the gas is heliox and the first and second inner diameters areselected so that the nebulizer receives a flow rate of about 16.5 LPM.12. The accessory of claim 1, wherein each of the first, second andthird legs is a tubular structure.
 13. The accessory of claim 1, whereinthe reservoir bag includes a first connector that is in communicationwith the first compartment and a second connector that is incommunication with the second compartment, the first connector beingslidingly and sealingly received within the first leg and the secondconnector being slidingly and sealingly received with the second leg.14. The accessory of claim 13, wherein the first connector includes asupplemental fluid port that permits introduction of a fluid into thefirst connector and into the first compartment of the reservoir bag andan inhalation valve disposed at an end of the first connector, theinhalation valve opening when the patient inhales to providecommunication between the supplemental fluid port and the main conduitbody.
 15. The accessory of claim 14, wherein the first leg includes afluid port that is in communication with the main conduit body, thefluid port being disposed between the inhalation valve at the end of thefirst connector and an entrance into the main conduit body.
 16. Theaccessory of claim 15, wherein the first connector comprises a tubularstructure that is received within a tubular structure of the first legsuch that the inhalation valve is contained within the first leg belowthe fluid port but above the supplemental fluid port.
 17. The accessoryof claim 1, wherein the main conduit body is formed of first and secondsections that are coupled together to form a unitary structure, thefirst section including the first leg and the second section includingthe second and third legs.
 18. An aerosol inhalation system comprising:a single source of gas; a Y-connector having a first port in fluidcommunication with the gas source via a first conduit and second andthird ports; an accessory having a main conduit body that includes afirst leg, a second leg, and a third leg, all of which are in fluidcommunication with the main conduit section, the first leg being fluidlyconnected to the second port of the Y-connector via a second conduitthat is connected to the second port and a first gas inlet portassociated with the first leg to permit gas from the single source toenter and flow through the first leg, the accessory including a patientinterface conduit that is adapted to deliver aerosolized medication to amouth of the patient; a nebulizer sealingly and removably disposedwithin the third leg, the nebulizer including a second gas inlet portthat is fluidly connected to the third port of the Y-connector to permitgas from the single source to flow into the nebulizer to create theaerosolized medication that is delivered into the main conduit body andto the patient through the patient interface conduit, wherein the firstgas inlet port has a first inner diameter and the second gas inlet portof the nebulizer has a second inner diameter which is greater than thefirst inner diameter; a holding chamber having a first compartment and asecond compartment separated from the first compartment, with the firstcompartment being sealingly and fluidly coupled to the first leg and thesecond compartment being sealingly and fluidly coupled to the secondleg, wherein the holding chamber is defined by a reservoir bag with thefirst and second compartments defined therein and separated from oneanother by a bi-furcating wall, the reservoir bag being formed of anexpandable/collapsible material; and an arrangement of valves includinga first inhalation valve, a second inhalation valve, and an exhalationvalve, the first inhalation valve being associated with the first leg soas to control the flow of the gas through the first gas inlet port andinto the main conduit body, the second inhalation valve being locatedwithin the main conduit body between the first leg and the third leg soas to control the flow of gas through the second gas inlet port and intothe main conduit body, wherein inhalation by the patient results in thefirst and second inhalation valves assuming open positions to permit gasto flow to the patient, the exhalation valve opening when the patientexhales, while the inhalation valves are closed, thereby preventing flowof gas to the patient.
 19. The accessory of claim 18, wherein the secondinner diameter is at least 10% greater than the first inner diameter.20. The accessory of claim 18, wherein the second inner diameter isbetween about 10% to about 20% greater than the first inner diameter.21. The accessory of claim 18, wherein the second inner diameter is atleast 20% greater than the first inner diameter.
 22. The accessory ofclaim 18, wherein the gas is oxygen and the first and second innerdiameters are selected so that the nebulizer receives a flow ratebetween about 8 LPM (liters per minute) to about 12 LPM.
 23. A method ofdelivering aerosolized medication to a patient comprising the steps of:connecting a single source of gas to a first port of a Y-connector via afirst conduit, the Y-connector having second and third ports; providingan accessory having a main conduit body that includes a first leg and asecond leg, both of which are in fluid communication with the mainconduit section, the accessory having a patient interface conduit thatis adapted to deliver aerosolized medication to a mouth of the patient;connecting the first leg to the second port of the Y-connector via asecond conduit to permit gas from the single source to flow through thefirst leg and into the main conduit body; disposing a nebulizer withinthe third leg and connecting a first gas inlet port of the nebulizer tothe source of gas via a third conduit that is connected to the thirdport of the Y-connector to permit gas from the single source to flowinto the nebulizer to create the aerosolized medication that isdelivered into the main conduit body and to the patient through thepatient interface conduit attaching a holding chamber to the first andsecond legs of the main conduit body, the holding chamber having a firstcompartment and a second compartment separated from the firstcompartment, with the first compartment being sealingly and fluidlycoupled to the first leg and the second compartment being sealingly andfluidly coupled to the second leg; and providing an arrangement ofvalves including a first inhalation valve, a second inhalation valve,and an exhalation valve, the first inhalation valve being associatedwith the first leg so as to control the flow of the gas into the mainconduit body, the second inhalation valve being located within the mainconduit body between the first leg and the third leg so as to controlthe flow of gas into the main conduit body, wherein the firstcompartment is located on one side of the second inhalation valve, whilethe second compartment is located on the other side of the secondinhalation valve such that gas flowing from the nebulizer flows into themain conduit body and enters the second compartment when the secondinhalation valve is closed due to the relative locations of the secondinhalation valve in the main conduit body and the second leg that formsan entrance to the second compartment; wherein the holding chamber isdefined by a reservoir bag with the first and second compartmentsdefined therein and separated from one another by a bi-furcating wall,the reservoir bag being formed of an expandable/collapsible material.24. The method of claim 23, wherein the step of connecting the first legto the second port of the Y-connector via a second conduit comprises thestep of connecting the second conduit to a second gas inlet port that isassociated with the first leg, and the method further includes the stepof: selecting an inner diameter of the second gas inlet port such thatit is less than an inner diameter of the first gas inlet port.
 25. Themethod of claim 24, wherein the gas is oxygen and the inner diameter ofthe second gas inlet port and the inner diameter of the first gas inletport are selected so that the nebulizer receives a flow rate betweenabout 8 LPM (liters per minute) to about 12 LPM.